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Medical device and health technology recalls from FDA. Includes diagnostic equipment, implants, monitors, and therapeutic devices.
There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns and lab coats.
There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns and lab coats.
Due to unqualified "design verification" batteries being shipped to customers.
Battery performance issues related to prolonged storage.
complaints of kinked access lines observed during treatment using cartridge sets for hemodialysis treatments were received.
complaints of kinked access lines observed during treatment using cartridge sets for hemodialysis treatments were received.
complaints of kinked access lines observed during treatment using cartridge sets for hemodialysis treatments were received.
complaints of kinked access lines observed during treatment using cartridge sets for hemodialysis treatments were received.
complaints of kinked access lines observed during treatment using cartridge sets for hemodialysis treatments were received.
Complaints were received for Self-drill Half-Pin tip breakages occurring during surgery.
Potential for the battery to lose its ability to be recharged.
Patient tabletop moved out to the home position during scan initialization, may cause operator/bystander staying by the rear of the table to collide with the moved tabletop and be injured
Device was distributed without a proper marketing authorization. This event is an expansion of RES 87581, Z-1355-2021 thru Z-1364-2021.
Device was distributed without a proper marketing authorization. This event is an expansion of RES 87581, Z-1355-2021 thru Z-1364-2021.
Device was distributed without a proper marketing authorization. This event is an expansion of RES 87581, Z-1355-2021 thru Z-1364-2021.
Device was distributed without a proper marketing authorization.
Device was distributed without a proper marketing authorization.
Device was distributed without a proper marketing authorization. This event is an expansion of RES 87581, Z-1355-2021 thru Z-1364-2021.
Device was distributed without a proper marketing authorization.
Device was distributed without a proper marketing authorization.